With Pfizer expecting to hear back on its 351(k) resubmission on a trastuzumab biosimilar in early 2019, Genentech and its parent, Roche, may have been getting nervous about their competitor’s intentions. After all, Pfizer was willing to launch at risk with its marketing of Inflectra®, the infliximab biosimilar manufactured by partner Celltrion. In fact, it … Continue reading Pfizer Signs Licensing Agreement With Roche on Trastuzumab Biosimilar
Tag: Roche
An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
Momenta seems to be in final preparations for its first 351(k) filing to the Food and Drug Administration (FDA). In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval. Despite this promising news, Momenta is facing strong headwinds. Even if it gains … Continue reading An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?
An upcoming presentation at the annual American Society of Clinical Oncology (ASCO) meeting promises equal efficacy and much improved safety for patients with early-stage breast cancer receiving Herceptin®. This change in trastuzumab dosing from a 12-month to a 6-month regimen will have ramifications for patients, health systems, and manufacturers. A number of biosimilar drug makers … Continue reading Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?
Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan
When Pfizer announced that it received a complete response letter from the Food and Drug Administration (FDA), the wait for an available biosimilar to Herceptin® just got longer. According to the manufacturer, the FDA specified that the reasons for the rejection of PF-05280014 were not related to clinical questions. The rejection was not associated with … Continue reading Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan
Mylan/Biocon Receive First Approval for Trastuzumab Biosimilar, but First to Market?
On December 1, the team of Mylan and Biocon received their first biosimilar approval in the US, for an agent to compete with Roche’s Herceptin®. The approval decision on this product was delayed 3 months owing to potential issues involving Biocon’s manufacturing facility. However, this marks the first biosimilar approved for trastuzumab, beating entries from … Continue reading Mylan/Biocon Receive First Approval for Trastuzumab Biosimilar, but First to Market?
Amgen Receives Approval for Bevacizumab Biosimilar
The Food and Drug Administration announced today the approval of the first biosimilar for Roche’s Avastin®. The approval of Mvasi™ (bevacizumab-awwb) represents the first biosimilar approved in the US for the direct treatment of cancer. Amgen is partnered with Allergan in the development and marketing of the new biosimilar.
FDA Advisory Committee Unanimously Recommends Approval for Avastin® and Herceptin® Biosimilars
Amgen and Allergan’s ABP-215 was convincingly presented as equivalent to Roche's bevacizumab (Avastin®). The totality of evidence, according to the FDA staff review documents, supported the 351(k) application by Mylan. The Advisory Committee agreed, voting 16-0 to recommend the biosimilar for approval for use in Herceptin’s indications.